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MCGB10S02 Millidisk® Cartridge 10-stack 0.22 µm hydrophobic

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MCGB10S02
2  Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberMCGB10S02
Trade Name
  • Millidisk®
DescriptionMillidisk® Cartridge 10-stack 0.22 µm hydrophobic
References
Product Information
HS Code8421 29 90
Device ConfigurationCartridge
Maximum Differential Pressure, bar (psid)Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)Forward - 4.1 bar (60 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 123 °C; Reverse - 0.7 bar (10 psi) @ 25 °C
Stack Design10 Stak
Cartridge CodeNot Applicable
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaDurapore®
SterilityOther
Sterilization5 SIP cycles of 30 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophobic
Physicochemical Information
Pore Size0.22 µm
Bubble Point at 23 °C≥1170 mbar (17.0 psig) nitrogen with 100% IPA
Gravimetric ExtractablesThe extractables level was equal to or less than 2.5 mg per sterilized device after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Filtration Area500 cm²
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polysulfone
Seal MaterialSilicone (SI)
Support MaterialPolysulfone
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size2
Material PackageEasy-Open bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Catalogue Number GTIN
MCGB10S02 04053252350023

Documentation

Certificates of Quality

Title
Millidisk 10 Capsule Durapore Membrane - C7PA84614
Millidisk 10 Cartridge Durapore Membrane C0AB87091
Millidisk 10 Cartridge Durapore Membrane C0DB57149
Millidisk 10 Cartridge Durapore Membrane C0DB61741
Millidisk 10 Cartridge Durapore Membrane C0MB14046Z
Millidisk 10 Cartridge Durapore Membrane C0SB89687Z
Millidisk 10 Cartridge Durapore Membrane C1HB85524Z
Millidisk 10 Cartridge Durapore Membrane C1JB85494Z
Millidisk 10 Cartridge Durapore Membrane C1JB85609Z
Millidisk 10 Cartridge Durapore Membrane C1KB85699Z
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Technical Info

Title
Best Practices for Managing Reverse Pressure Filter Impact
Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters

Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Hydrophilic Durapore® Cartridges and Capsules User Guide